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Deprecated: Implicit conversion from float 332.4 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Trials 2020 ; 21 (1): 8 Nephropedia Template TP
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Treatment of Middle East respiratory syndrome with a combination of lopinavir/ritonavir and interferon-beta1b (MIRACLE trial): statistical analysis plan for a recursive two-stage group sequential randomized controlled trial #MMPMID31900204
Arabi YM; Asiri AY; Assiri AM; Aziz Jokhdar HA; Alothman A; Balkhy HH; AlJohani S; Al Harbi S; Kojan S; Al Jeraisy M; Deeb AM; Memish ZA; Ghazal S; Al Faraj S; Al-Hameed F; AlSaedi A; Mandourah Y; Al Mekhlafi GA; Sherbeeni NM; Elzein FE; Almotairi A; Al Bshabshe A; Kharaba A; Jose J; Al Harthy A; Al Sulaiman M; Mady A; Fowler RA; Hayden FG; Al-Dawood A; Abdelzaher M; Bajhmom W; Hussein MA
Trials 2020[Jan]; 21 (1): 8 PMID31900204show ga
The MIRACLE trial (MERS-CoV Infection tReated with A Combination of Lopinavir/ritonavir and intErferon-beta1b) investigates the efficacy of a combination therapy of lopinavir/ritonavir and recombinant interferon-beta1b provided with standard supportive care, compared to placebo provided with standard supportive care, in hospitalized patients with laboratory-confirmed MERS. The MIRACLE trial is designed as a recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The aim of this article is to describe the statistical analysis plan for the MIRACLE trial. The primary outcome is 90-day mortality. The primary analysis will follow the intention-to-treat principle. The MIRACLE trial is the first randomized controlled trial for MERS treatment. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02845843. Registered on 27 July 2016.